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Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC

NCT07663747 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-06-25

No results posted yet for this study

Summary

This is a Phase 2 clinical intervention trial to assess efficacy of induction EVP to spare the bladder in stage T2-4aN0-1 urothelial bladder cancer (UBC), using a response-adapted approach

Conditions

  • Urothelial Bladder Cancer

Interventions

DRUG

Enfortumab Vedotin

Induction: 4 cycles (d1,8; 1.25 mg/kg)

DRUG

Pembrolizumab

Induction: 4 cycles 200mg and after cCR 400 mg q6 weeks. Total 1 year from start of therapy

RADIATION

Radiation

The preference will be a four-week schedule, in which 55 Gy radiotherapy will be administered using intensity modulated radiation therapy (IMRT)

OTHER

Chemoradiation

by local protocol; by local protocol; Mitomycin C/fluoropyrimidines in the Netherlands) * No disease outside the bladder (e.g. involvement of ureter, prostatic urethra or (suspected) lymph node metastases) * No bilateral hydronephrosis * No multifocal CIS * Adequate bladder function: Post-micturition residual volume of \< 200 cc, International Prostate Symptom Score (IPSS) \< 15 points; revised urinary incontinence scale \< 8 points; no daily or continuous catheter use.

PROCEDURE

Cystectomy

Surgical removal of the bladder

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Michiel S van der Heijden, MD,PhD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2031-04-01
Completion
2032-04-01

Countries

  • Netherlands

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07663747 on ClinicalTrials.gov